Table 1.
Therapeutic applications authorized in the United States and Japan
| Device name | Target patient | Function | Medical specialty | Priority review | Company | Authorization | 510(k)/DeNovo |
|---|---|---|---|---|---|---|---|
| The United States | |||||||
| reSET | Substance use disorder | Cognitive behavioral therapy modeled on the community reinforcement approach. The content of the therapy lessons is delivered via text, video, animations and graphics. | Neurology | N/A | Pear Therapeutics Inc. | 9/14/2017 | De Novo |
| reSET-O | Opioid use disorder | Cognitive behavioral therapy modeled on the community reinforcement approach. The content of the therapy lessons is delivered via text, video, animations and graphics. | Neurology | Breakthrough device | Pear Therapeutics Inc. | 12/10/2018 | 510(k) |
| Somryst | Chronic insomnia | Cognitive behavioral therapy based on principles of insomnia, sleep restriction, and other proven psychosocial treatment elements. The content of the therapy lessons is delivered via text, video, animations and graphics. | Neurology | Pre-certification program | Pear Therapeutics Inc. | 3/23/2020 | 510(k) |
| EndeavorRx | Attention deficit hyperactivity disorder | Video game is built on Akili’s proprietary, patented, technology platform and uses adaptive algorithms to deliver stimuli that are designed to engage the patient in a manner that improves their attention function. | Neurology | N/A | Akili Interactive Labs Inc. | 6/15/2020 | De Novo |
| NightWare | Nightmare disorder related to PTSD | Smartwatch-based application that senses physiological signals that are consistent with a nightmare utilizing the heart rate sensor, accelerometer, and gyroscope. When the threshold of stress index (device specific indicator) is exceeded, the smartwatch is programmed to provide vibrotactile stimulation on the patient’s wrist to arouse the patient out of the distressed state. | Neurology | Breakthrough device | NightWare, Inc. | 11/06/2020 | De Novo |
| Parallel | Irritable bowel syndrome | Cognitive behavioral therapy (CBT) to influence the communication between your brain and gut to improve IBS. The therapy provides guidance based on the personal biological, environmental, and psychological aspects of patients IBS. | Gastroenterology | N/A | Mahana Therapeutics, Inc. | 11/25/2020 | De Novo |
| Japan | |||||||
| The CureApp smoking cessation system | Nicotine dependence | Cognitive behavior therapy accordance with the national guidelines for smoking cessation. The content of the therapy lessons is delivered via messages and educational video, counseling chat sessions and diary. | Respiratory | N/A | CureApp Inc. | 8/21/2020 | Brand-new |